Source document: https://docs-lawep.s3.us-east-2.amazonaws.com/1698943423524.pdf (Uganda)
Key ministries to be involved in implementing this law include; Finance, Planning and Economic Development / UNCST Agriculture, Animal Industry and Fisheries Water and Environment Health UBBC UGANDA BIOTECHNOLOGY & BIOSAFETY CONSORTIUM The National Biotechnology and Biosafety Bill, 2012: Simplified Version (Bill No 18 of 2012, Republic of Uganda) Purpose of the Bill • The Bill is for an Act to ensure the safe development and use of modern biotechnology; • To provide mechanisms to regulate research, development and use of genetically modified organisms.
Key terms used in the Bill The Bill defines the following: (a) “biosafety” means the safe development, transfer, application and utilisation of biotechnology and its products (b) “biotechnology” means any technique that uses living organisms or substances from living organisms to make or modify a product, improve plant, animal breeds or micro- organisms for specific purposes (c) “genetically modified organism or GMO”(also called transgenic or product of modern biotechnology) means an organism, consisting of any of the genes or other genetic material that have either been:– • modified by means of modern biotechnologies; or • inherited from genes or other genetic material which were so modified.
Objectives of the Bill (clause 2)  to ensure the safe development and use of modern biotechnology for national development;    to establish procedures application and approval to use modern biotechnology at various levels including research and general release; to strengthen consumer protection and public understanding of products and the benefits of biotechnology; to build human and institutional capacity to promote safe generation and use of modern biotechnology products.
, 2 0 1 2 Institutional framework; Roles in biosafety management in Uganda National Focal Point Ministry of Water and Environment • Provide information to Secretariat to Convention on Biological Diversity and other international organisations • Coordinate exchange of information between relevant ministries and departments of government (cl.
4,5) General public Institutional Biosafety Committees (IBCs) • Approve laboratory and contained testing • Review, monitor and supervise laboratory experiments, contained and confined testing • Recommend applications for confined testing and general release to Competent Authority Other Government Agencies • Health • Agriculture • Trade • Standards • Environment, etc.

Competent Authority (UNCST) • Approve research, testing and general release of GMOs.
• Give information to National Focal Point • Set standards and issue guidelines on safety, research and testing • Approve institutional biosafety committees • Supervise IBCs (cl.

6,7) Ministry of Finance, Planning and Economic Development • Appoint chairperson and members of NBC (Cl.9) • Determine appeals from decisions of Competent Authority (cl.

41) • Make Regulations under the Act.

(cl.


44) National Biosafety Committee (NBC) • Review applications for testing and general release • Advise Competent Authority on fees, new scientific information, comments received from the public • Advise Competent Authority on implementation of Act (cl.
9,10) • Recommend mitigation measures in biotechnology use UBBC 2 Registrar of Biotechnology and Biosafety • Receive and screen applications for GMOs • Register all institutions engaged in biotechnology and biosafety • Register approved Institutional Biosafety Committees • Prepare and issue certificates, permits and Advance Informed Agreements , 2 0 1 2 Approval of research and development of biotechnology Stage / type of R&D Approving Authority Max.
Review period (working days) Remarks Laboratory experiments Contained testing Confined field trial IBCs IBCs General release Import, Export, transit Competent Authority (UNCST) Competent Authority (UNCST) Competent Authority (UNCST) 21 28 90 270 Competent Authority is notified Competent Authority is notified IBC recommends IBC recommends; Other government agencies & public are consulted; Gazette 28 Fulfill Cartagena PB W/A • UNCST: Uganda National Council for Science and Technology • All approval by competent authority based on advise from NBC Risk and safety assessment • All GMO research and development activity approvals are based on thorough risk and safety assessment • The risk and safety assessment shall be carried out in accordance with international best practices and guidelines • All applications must contain emergency plans to manage unintentional environmental releases Restoring damage caused by a GMO In the event that an activity involving a GMO causes damage to human health or the environment, the Competent  Authority may issue a restoration order to the person causing the damage.
Such orders can also be issued for  Activities relating to a GMO without or beyond the approval of the Competent Authority;  In cases of damage caused by the unintentional release of a GMO attributable to a person; Where the Competent Authority has issued an order to the person to stop research or general release of a  GMO; In any other cases where the activity of a person has caused damage.
Cl.31 3 UBBC , 2 0 1 2 Offences and penalties Offence Penalty Research or making general release of a GMO without approval Failing to disclose any information as required by this Act Max.

120 currency points or max.

5 years or both Max.

48 currency points or max.

24 months or both Furnishing false information Max.

48 currency points or max.
24 months or both Releasing or using any confidential information for any purpose not authorized under the Act Using a GMO in a manner inconsistent with the approval granted under the Act Using a GMO to deliberately harm or injure the environment or human health Obstructing the Competent Authority or an officer of the Competent Authority from the performance of their duties under the Act Neglecting, refusing or failing to take emergency safety measures in case of unintentional release of a GMO a Max.
48 currency points or max.

24 months or both Max.

24 currency points or max.

12 months or both Max.

240 currency points or max.

10 years or both Max.

24 currency points or max.

12 months or both Max.

120 currency points or max.

5 years or both One currency point is currently equivalent to UGX 20,000 and is set by the government.
Regulations Schedules The Minister responsible for science and technology may, after consultation with the Competent Authority, make regulations for the purpose of carrying into effect the provisions of this Act.

Some of these  regulations will include:   Procedures for conducting research Procedures for general release Procedures for handling, transport, labeling, packaging    Bioethical considerations Penalties Any other regulation for effective implementation 1.

Currency point 2.
Currency point 2.

NBC conduct of business 3.

Forms a.

Lab research b.

Contained testing c. Confined testing d. General release e. Import/export, transit 4.

Risk and safety assessment procedure of the proposed Act.

Published by Uganda Biotechnology and Biosafety Consortium (UBBC) c/o Uganda National Council for Science and Technology Plot 6, Kimera Road, Ntinda P. O.

Box 6884, Kampala- Uganda Tel: +256 714110088 +256 772585211 Email: ubbconsortium@gmail.com UBBC 4